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Luminopia One Pilot Study

Sponsor
Luminopia (Industry)
Overall Status
Completed
CT.gov ID
NCT02782117
Collaborator
Boston Children's Hospital (Other)
84
Enrollment
9
Locations
1
Arm
18.2
Actual Duration (Months)
9.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.

Condition or Disease Intervention/Treatment Phase
  • Device: Luminopia One
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A single-arm, multi-center, open-label pilot study conducted in two phases. Phase 1 enrolled 10 participants at 1 site and phase 2 enrolled 74 participants at 9 sites.A single-arm, multi-center, open-label pilot study conducted in two phases. Phase 1 enrolled 10 participants at 1 site and phase 2 enrolled 74 participants at 9 sites.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Luminopia One Pilot Study
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Feb 6, 2019
Actual Study Completion Date :
Feb 6, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Regimen A

Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks.

Device: Luminopia One
Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.

Outcome Measures

Primary Outcome Measures

  1. Amblyopic eye best-corrected visual acuity [12 weeks]

    Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age

Secondary Outcome Measures

  1. Amblyopic eye best-corrected visual acuity [8 weeks]

    Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age

  2. Amblyopic eye best-corrected visual acuity [4 weeks]

    Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age

  3. Adherence [12 weeks]

    Duration spent using the device divided by duration of treatment prescribed (objectively monitored)

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Major Eligibility Criteria:

  • Age 4 to <8 years (phase 1) or age 4 to <13 years (phase 2)

  • Monocular amblyopia associated with anisometropia, strabismus or both combined

  • Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR)

  • Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2)

  • Interocular BCVA difference ≥3 lines (≥0.3 logMAR)

  • Visual acuity stability in current refractive correction (phase 2)

  • Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Physicians of Central Florida Maitland Florida United States 32751
2 Wheaton Eye Clinic Chicago Illinois United States 60187
3 Indiana University Bloomington Indiana United States 47405
4 Kids Eye Care of Maryland Frederick Maryland United States 21703
5 Children's Eye Care of Michigan Dearborn Michigan United States 48124
6 Concord Eye Center Concord New Hampshire United States 03301
7 Conestoga Eye Lancaster Pennsylvania United States 17601
8 Houston Eye Associates Houston Texas United States 77025
9 Virginia Pediatric Eye Center Virginia Beach Virginia United States 23452

Sponsors and Collaborators

  • Luminopia
  • Boston Children's Hospital

Investigators

  • Study Director: David Hunter, MD PhD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luminopia
ClinicalTrials.gov Identifier:
NCT02782117
Other Study ID Numbers:
  • C-AM-1C AND C-AM-1D
First Posted:
May 25, 2016
Last Update Posted:
Jul 9, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Amblyopia

Study Results

No Results Posted as of Jul 9, 2020